Not Yet RecruitingNot Applicable

A Scientific Evaluation of One or Two Doses of a Vaccine Against Human Papillomavirus: Long Term Follow Up of Gardasil9 Recipients in the ESCUDDO Study ("Estudio de Comparación de Una y Dos Dosis de Vacunas Contra el Virus de Papiloma Humano [VPH]")

Costa Rica9,700 participantsStarted 2026-08-03

Plain-language summary

This study evaluates the long term protection provided by either one or two doses of the HPV vaccine for patients who were part of the ESCUDDO study.

Who can participate

Age range

12 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * \* Participation in ESCUDDO base study * Randomization (excluding the two participants who had major protocol deviations in the ESCUDDO base study) to the Gardasil9 1- and 2-dose arms * A signed informed consent form for ESCUDDO LTFU. * Opportunity to complete three total study visits Exclusion Criteria: * \* Enrollment cannot occur beyond her 10 year study visit

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

First type-specific occurrence of HPV6/11/16/18/31/33/45/52/58-related 6-months cervicovaginal persistent infection

Timeframe: Up to study completion

First any-type occurrence of HPV6/11/16/18/31/33/45/52/58-related 6-months cervicovaginal persistent infection

Timeframe: Up to study completion

Trial details

NCT IDNCT07706673

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeOBSERVATIONAL

Primary completion2030-10-01

View on ClinicalTrials.gov More Human Papillomavirus-Related Malignant Neoplasm trials